WAXHEAD BABY SUNSCREEN SPF 35- sunscreen cream

Waxhead Baby Sunscreen SPF 35 by

Drug Labeling and Warnings

Waxhead Baby Sunscreen SPF 35 by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

25% Non-Nano Zinc Oxide (Uncoated, French Process)

Purpose

Sunscreen

Inactive Ingredients

Spring water (aqua), Extra virgin olive oil* (oleo europaea fruit oil), Beeswax* (cera alba), Non-GMO Vegetable Vitamin E (tocopherol), Vitamin D3 (cholecalciferol). *Certified Organic by USDA/NOP

Uses

Helps prevent sunburn. If used as directed with other sun protection
measures, decreases risk of skin cancer and skin aging caused by sun.

Warnings

For external use only. Keep product out of eyes. Rinse with water to
remove. Do not use on damaged skin. Stop use and ask a doctor if rash
develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of the reach of children. If ingested, consult a Poison Control Center Immediately.

DOSAGE & ADMINISTRATION

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply:
• after swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 AM – 2 PM.
• Wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months. Ask a doctor

Directions

​Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of
swimming or sweating, immediately after towel drying, or every 2 hours.

Sun Protection Measures. Exposure to sun increases risk of skin cancer
and skin aging. To decrease risk, regularly use sunscreen with broad
spectrum SPF 15 or higher and other sun defense measures including:
limit time in the sun, especially from 10 AM to 2 PM, wear long sleeve
shirts, pants, hats and sunglasses. Children under 6 months, ask a doctor.

Other Information

Keep this product away excessive heat and direct sun. Shake before use.

Questions?

Contact Waxhead Sun Defense gowaxhead.com.

Package Label

INGREDIENTS AND APPEARANCE

WAXHEAD BABY SUNSCREEN SPF 35 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)	4.75 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	1.25 g  in 100 g
WATER (UNII: 059QF0KO0R)	2 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	67 g  in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	0.000000335 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1204-1	115 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2016

Labeler - Kabana Skin Care (080237112)

Registrant - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-1204)